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Challenges and Opportunities For Medical Disposables &
Implants Industry in India
Stakeholders need to take cognizance of
the fact that it is not a desirable situation for a
country with over a billion population to be 70 per cent
import dependent on medical devices. Besides affordability
of healthcare (which is currently 75 per cent out of
pocket), the three pillars of medical technology remain
safety, quality and efficacy of devices. At present, there
is no nodal agency for assessing and evaluating technology
in India.
The government should have a separate
department under the Ministry of Health and Family Welfare
(MoH&FW). The medical devices cater more to the healthcare
than the pharmaceutical sector. Too many governing bodies
with diverse requirements and standards, viz Department of
Pharmaceuticals, Bio Technology, Telecommunications,
Ministry of Environment and Forest, Ministry of Science
and Technology, Ministry of Commerce, are hindrance to
promotion of new technology. These affect ease of doing
business as the decision making becomes slow. For the
industry to grow and make it a hub, we need a nodal
department which focusses on the segment.
Product performance reports are a globally
accepted means of showing efficacy of medical technology,
an aspect which has not found the same degree of
importance in drafting policy and regulation. In other
words, a onesize-fits-all approach may not work here and
careful mapping of the medtech landscape is needed to
identify the devices and equipment that are viable to
making in India.
National Pharmaceutical Pricing
Authority’s (NPPA) and Department of Pharmaceuticals are
in discussion about categorization of medical devices into
different segments for the purpose of fixing of trade
margins. But the medical devices industry is continuing to
be divided on the move of rationalization of trade
margins. Rationalization of the price is necessary through
an average pricing formula. The industry also suggests :
• Transparent and evidence based pricing
and reimbursement policies should be promoted
• No arbitrary price control mechanisms should apply
• Recently Government broadened Medical Device definition
to attract FDI. – delinked with D&C Act – (Same should
apply for Rules & Regulations)
The industry welcomes CDSCO’s recent
notification on waving off ADC/NOC condition of export
consignments to all countries. This was a long standing
demand of domestic manufacturers. This waiver of ADC/NOC
will reduce the procedures for export clearance from the
port where shipments were getting delayed for requirement
of additional paper work. This is an important step taken
by CDSCO to accelerate exports and reduce bottle necks for
domestic manufacturers.
Also, the Ministry of Environment and
Forest notified last month exclusion of Blood Bags from
Bio Medical Waste Management Rules. The rules suggested
phase out use of chlorinated plastic bags and gloves. The
industry is concerned as there is no alternative to some
of the chlorinated bags (Urine Bags, Drainage bags etc.).
The removal of existing barriers for
growth & innovative initiatives from government will
ultimately lead to increased investment in the Indian
Medical Devices Industry by domestic and global players
alike, whether in the form of local manufacturing,
fostering Research & Development and Innovation,
partnerships for skill development, among other things.
All stakeholders can work together today
to contribute for the future vision of “Affordable and
quality healthcare to all”.
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Poly Medicure Ltd.
Poly Medicure Ltd is one of the leading medical
devices manufacturer and exporter from India with
dominant position in medical consumables market over
20 years with focus on innovation, safety and quality
and have a vision of a world with highest quality of
healthcare is made available to all. POLYMED have 5
manufacturing facilities in India (3 facilities in
Faridabad and 1 each in Jaipur and Haridwar), 2
facilities overseas (One facility in China – wholly
owned subsidiary and One joint venture in Egypt.)
Poly Medicure has spent Rs. 60 crore on the new green
field project at IMT Faridabad, another 50-60 crore
will be spent on the capacity expansion, automation
and new products to be launched. Polymed produces over
100 different types of medical devices, the category
ranges from Infusion Therapy, Central Venous Catheter,
Blood Management System, Surgery and Wound Drainage,
Anesthesia, Urology and Dialysis. With 98% percent of
products of the renal care imported, the company will
launch portable artificial kidney dialyser, which will
help in continuous blood cleansing. A filter developed
indigenous in India will help decrease the cost and
more people will be able to afford it. |
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